Compassionate Use of 131I-MIBG Therapy for Patients with Hard-to-Treat Neuroblastoma and Metastatic Pheochromocytoma

Sponsor: Northwell Health

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03015844

Provider View

This study offers a special treatment option for patients with progressive neuroblastoma or metastatic pheochromocytoma who have not responded to standard treatments. It aims to assess the benefits and side effects of 131I-MIBG therapy.

Patient Parameters

Program Overview

This study provides access to 131I-MIBG therapy for patients with neuroblastoma or pheochromocytoma that has not improved with other treatments. The goal is to see if this therapy can help relieve symptoms and to understand its side effects. Researchers will look at how well the treatment works, any side effects, and how long it takes for the disease to progress or for patients to pass away.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with neuroblastoma or pheochromocytoma that has returned or not responded to treatment.
  • The disease must be getting worse, shown by new growths or an increase in size of existing ones, or not responding to standard treatments.
  • Must show uptake of MIBG in the tumor within 6 weeks before joining the study.
  • Must have waited at least two weeks after chemotherapy and three months after certain types of radiation before starting the study.
  • Must have enough healthy blood cells and organ function, including liver, kidney, and heart health.
  • Must have a certain number of stem cells available for re-infusion after treatment.
  • Must have a life expectancy of more than 8 weeks and be able to perform daily activities at least half of the time.

Exclusion Criteria

  • Cannot be pregnant or breastfeeding.
  • Cannot have severe organ disease that would interfere with participation.
  • Cannot have a severe active infection.
  • Cannot have MIBG-avid disease in the brain.
  • For pheochromocytoma patients, if urine tests show high protein levels, they cannot participate.

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